Allogeneic Blood Stem Cell Transplantation and Adoptive Immunotherapy for Hodgkin's Disease
The goal of this clinical research study is to learn if fludarabine, melphalan and gemcitabine followed by transplantation of stem cells (blood-forming cells) as well as immune cells (lymphocytes), collected from a matched related (i.e. a sibling) or unrelated donor, or a mismatched related donor, can help to control Hodgkin's disease. The safety of the treatment will also be studied.
Drug: Antithymocyte Globulin
Procedure: Allogeneic Stem Cell Infusion
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Allogeneic Stem Cell Transplantation Followed By Adoptive Immunotherapy for Patients With Relapsed and Refractory Hodgkin's Disease|
- Transplant Related Mortality [ Time Frame: Transplant to 100 days post transplant ] [ Designated as safety issue: Yes ]
|Study Start Date:||July 2005|
|Estimated Primary Completion Date:||July 2014 (Final data collection date for primary outcome measure)|
Experimental: Gemcitabine + Fludarabine + Melphalan
Gemcitabine 800 mg/m^2 IV Over 30 Minutes x 1 Day. Fludarabine 33 mg/m^2 IV. Melphalan 70 mg/m^2 IV Over 30 Minutes x 2 Days. Antithymocyte Globulin 2 mg/kg IV for two days before stem cell transplantation. If you are receiving a transplant from a matched unrelated donor (not a blood relative), a mismatched related donor (a blood relative, but not a full match), or receiving a cord blood transplant. Infusion of stem cells on Day 0.
800 mg/m^2 IV Over 30 Minutes x 1 Day
Other Names:Drug: Fludarabine
33 mg/m^2 IV Over 30 Minutes x 4 Days
Other Names:Drug: Melphalan
70 mg/m^2 IV Over 30 Minutes x 2 DaysDrug: Antithymocyte Globulin
2 mg/kg IV for two days before stem cell transplantation.
If you are receiving a transplant from a matched unrelated donor (not a blood relative), a mismatched related donor (a blood relative, but not a full match), or receiving a cord blood transplant.
Other Names:Procedure: Allogeneic Stem Cell Infusion
Infusion of stem cells on Day 0.
The main drugs used in this study are fludarabine, melphalan and gemcitabine. Fludarabine is a drug designed to weaken the immune defenses in order to allow the body to accept donors' cells. Melphalan is a chemotherapy drug that weakens the immune system but also kills cancer cells present in the body. Gemcitabine is a chemotherapy drug that kills cancer cells present in the body.
If you are found to be eligible to take part in this study, you will have a plastic tube (catheter) inserted into a vein under the collarbone. Drugs, blood products, and stem cells will be given and taken through this tube.
Gemcitabine will be given by vein or through the catheter for one day. Fludarabine will be given through the catheter once a day for 4 days. You will also receive melphalan once daily for 2 days. If you are receiving a transplant from a matched unrelated donor (not a blood relative), a mismatched related donor (a blood relative, but not a full match), you will also receive antithymocyte globulin (ATG) once a day for 2 days. ATG is given to decrease the risk of graft-versus-host disease. Tacrolimus will also be given to all patients to decrease the risk of (or treat) graft-versus-host disease. All participants are expected to need blood transfusions as part of this treatment.
Beginning 2 days before the transplant, tacrolimus will be given through the catheter over 24 hours. This will be changed to pills once you can tolerate swallowing pills. If no active cancer is detected and there is no graft-versus-host disease, you will then swallow 1 or more tacrolimus pills a day for only about 3-4 months, instead of the usual period of 6 months. This is done to boost the donor immune system against the cancer.
On the transplant day ("Day 0"), the stem cells or bone marrow collected from the donor will be infused through the catheter ("transplant"). You will receive a mixture of stem cells and immune cells. Drugs such as corticosteroids, acetaminophen (Tylenol), and/or Benadryl will be given through the catheter, before the infusion, to decrease the chance of allergic reactions. Starting on Day 7 after the transplant, filgrastim (G-CSF) will be given as an injection under the skin or through a needle to increase the growth of white blood cells. Methotrexate, a chemotherapy drug, will be given in small doses through the catheter on Days 1,3,6, 11 after the transplant to decrease the risk of graft-versus-host disease (GVHD).
If you have persistent but stable (not "growing") disease after transplant, you will have your immunosuppressive medications (tacrolimus, corticosteroids) stopped even before 4 months. If there is no response, you will receive an infusion of additional cells from your donor. If you have progressive ("growing") Hodgkin's disease after the transplant, you will be taken off study, and other treatment options may be explored.
Blood, bone marrow, and x-ray examinations will be performed periodically to monitor the results of the bone marrow transplantation. Blood tests will usually require up to 3-4 tablespoons of blood. These examinations will be done before the transplant, before you are released to go back home (about 100 days after the transplant), and then as deemed necessary by your physician. Blood tests will be done daily while you are hospitalized and several times a week until your blood counts recover.
This is an investigational study. All of the drugs used in this study are FDA-approved and commercially available. Up to 70 patients will take part in this study. All will be enrolled at MD Anderson.
|Contact: Paolo Anderlini, MD||713-792-8750|
|United States, Texas|
|UT MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Principal Investigator: Paolo Anderlini, MD|
|Principal Investigator:||Paolo Anderlini, MD||M.D. Anderson Cancer Center|